FDA-Drug2025-07-09Class II

Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0

The Harvard Drug Group LLC
Hazard

Defective container; blister packaging inadequately sealed.

Sold states
Nationwide
Affected count
3,527 bags
Manufactured in
7000 Cardinal Pl, Dublin, OH, United States
Products
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0508-2025

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